Medtronic Recalls Valleylab Laparoscopic Wire J-Hook Electrode Due to Sterility Risk
Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes due to a potential package compromise that could breach the sterile barrier.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile barrier breach) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes (Item Code: E278228) because of a potential for compromise of the package resulting in a breach of the sterile barrier. The affected lot range is 209822X through 61220117X.
These devices are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation, and suction via a single handset is desirable. The recall covers units distributed worldwide, including the United States, Australia, Canada, Japan, Korea, Hong Kong, and Thailand.
Healthcare facilities should stop using the affected devices and contact Medtronic for instructions on return or replacement. Patients who have had procedures using these devices should contact their healthcare provider if they have concerns.
The recalled product
- Product
- Valleylab Laparoscopic Wire J-Hook Electrode 28CM Item Code: E278228 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a…
- Manufacturer
- Medtronic
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Affected Lot Range: 209822X through 61220117X
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by Medtronic under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 25 products in this recall →Related recalls
Same manufacturer · Medtronic
See all →- HighMedtronic Recalls USPACK Suture Kits Due to Potential Seal Defects
FDA (Devices) · 2017-06-21
- HighMedtronic Recalls Best Practice Kits Due to Potential Seal Defects
FDA (Devices) · 2017-06-21
- HighMedtronic Recalls Pacemaker Angio X3 Due to Potential Seal Defect
FDA (Devices) · 2017-06-21
- ModerateMedtronic Recalls Polysorb Sutures Due to Potential Incomplete Seal
FDA (Devices) · 2017-06-21
- SevereMedtronic Recalls Custom Suture Packs Due to Potential Seal Defects
FDA (Devices) · 2017-06-21
Same hazard · sterility breach
See all →- HighMedline Open Heart A Pack Kits Recalled for Sterility Concerns
FDA (Devices) · 2026-09-23
- HighAVID Medical Recalls Halyard IV Start Kits Due to Seal Defects
FDA (Devices) · 2026-09-16
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline C-Section Prep Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
Similar recalls
- HighValleylab Laparoscopic Handset Recalled for Activation Button Failure
FDA (Devices) · 2017-04-26
- HighMedtronic Intact Disposable Wands Recalled for Sterility Compromise
FDA (Devices) · 2017-02-08
- HighMedtronic Intact Disposable Wands Recalled Due to Sterility Compromise
FDA (Devices) · 2017-02-08
- HighMedtronic Disposable Gloves Recalled for Potential Sterility Compromise
FDA (Devices) · 2016-10-26
- HighMedtronic Recalls Clearify Visualization Systems Due to Sterility Compromise
FDA (Devices) · 2016-12-28
- HighMedtronic DLP Aortic Root Cannula Recalled for Potential Sterility Breach
FDA (Devices) · 2024-11-13